Regulatory Watch

Biotech firms face new issues as FDA weighs policies to streamline generic-drug approvals and reduce patent disputes.

FDA's plan to establish pharmacogenomic policies spurs concerns among manufacturers, particularly in regard to how the policies will affect new-drug testing and approval.

FDA resolves the bar code labeling debate, releases its GMP requirements for dietary supplements, and proposes a comprehensive adverse-event reporting system.

Regular update from Washington.

FDA's newly launched risk-based approach to GMP regulation spurs signficant changes in the agency's approach to inspection processes, postapproval changes, and 21 CFR Part 11 enforcement.

Concerns about the safety and efficacy of dietary and herbal products are generating manufacturing requirements and analytical standards for ingredients.

Health experts are recognizing teh need to plan for global manufacturing of new treatments for AIDS and other diseases.

The establishment of a Medicare pharmacy benefit tops the to-do list of industry-related policy issues for 2003.

Reform legislation about generic drugs remains at the forefront of debate as innovator companies poise to challenge FDA proposals regarding patent laws.

FDA is juggling momentous changes, including new leadership and the proposed transfer of oversight for therapeutic biotech drugs.

FDA is set to revise CGMPs to encourage new manufacturing technologies and develop improved agency policies to ensure drug quality and safety.

Congress debates legislation for a Medicare drug benefit while the industry expresses concerns about import control, drug counterfeiting, and patent rights.

In response to increasing concern about drug safety, FDA has implemented several administrative and policy changes, inclduing the new Office of Pharmacoepidemiology and Statistical Science and a renewed focus on risk assessment.

To fund expanded FDA operations designed to streamline drug development and approval, FDA and industry representatives have negotiated the Prescription Drug User Fee Act III.

FDA cites manufacturing difficulties as a main contributing factor to recent drug shortages, which mainly involve injectibles and vaccines.

ICH continues its efforts to establish universal drug development standards and testing as pharmaceutical manufacturers press for additional FDA guidance on specifications.

Proposed funding increases for FDA reflect plans to significantly increase user fees collected from manufacturers under the Presciption Drug User Fee Act.

FDA wants manufacturers to revise product labeling and packaging and step up adverse-event monitoring to reduce risky product use.

FDA's Center for Drug Evaluation and Research is driving efforts toward creating initiatives to streamline regulatory processes, speed up drug production, and reduce costs.

Pharmaceutical companies will face a number of issues and challenges this year that will affect their resources, operations, and the markets they serve.

Anthrax contamination has put pharmaceutical quality and supply issues on the front page, along with patent and pricing policies.

Threats of bioterrorism generate new reulatory policies to protect the public against biological warfare.

FDA may adopt new requirements to enhance the safe use of pharmaceuticals and ensure that all US drugs are available when needed.

Providing prescription drug benefits for senior citizens is a pressing issue for Congress, pharmaceutical manufacturers, pharmacies, and ultimately the beneficiaries of proposed plans.

The Center for Drug Evaluation and Research is adopting new approaches to how it oversees the development and approval of new drugs and how it ensures the safe use of prescription drugs by the public.

FDA's new initiatives for the safe use of prescription drugs try to balance manufacturers' concerns about increased regulations with a low-risk approach to patient safety.